Quality Operations Graduate

3 weeks ago

Ireland Astellas Ireland Full time

Quality Operations Graduate About Astellas: At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions. We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn't a buzzword - it's a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes. Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care. The Opportunity: Your main function in this position is to ensure products produced for our patients is of the highest quality and meets all predetermined requirements and standards. Key Responsibilities: Line Clearance: - Execute Line Clearance checks in accordance with approved procedures and GMP requirements. - Assess and report any critical or non-critical line clearance incidents. Batch Record Review: - Ensure batch records are reviewed promptly in accordance with SLAs. - Perform quality reviews of batch records to ensure all batches are suitable for release by the QP. - Document and report batch record errors to Production to reduce the number of errors occurring. Quality Representative (Production): -Participate in SDI meetings and ensure effective investigation and assessment of quality issues and productivity initiatives related to Production & Engineering. - Liaise with departments on the shop floor to prevent quality issues, conduct on-line quality impact assessments, and coach/advise line personnel on compliance and best practices. - Involve in Risk Assessments as required, while demonstrating thorough knowledge of processes, procedures, equipment, and controls. Essential Knowledge & Experience: Process Orders and completion of Cleaning Validation activities. Preparation and maintenance of the weekly shipping schedule. Lead or participate in lean initiatives as required. Quality Management System: Conduct quality investigations, author documents, and complete eQMS records. Preferred Experience: Industrial/ Pharmaceutical experience would be advantageous. Education: Third level qualification in an Engineering, Science discipline or equivalent. Additional information: This is a graduate scheme opportunity. Position is based in Kerry, Ireland. This position requires you to be 100% on site. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. #LI-Kerry #LI-Onsite To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.

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